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Starpharma (ASX:SPL) yesterday announced that its two phase 3 trials of VivaGel BV for prevention of recurrent bacterial vaginosis (rBV) achieved their primary objective, demonstrating statistically significant superiority compared to placebo in preventing rBV based on topline data. The company intends to submit a marketing application to the FDA based on these positive results.
Bacterial vaginosis (BV) is the most common cause of vaginal infection for women of childbearing age. A highly recurrent condition, it is caused by an imbalance of naturally occurring bacterial flora. If left untreated, BV can cause a range of serious medical problems — including pelvic inflammatory disease, infertility, premature delivery and miscarriage, low birth weights and uterine infection — as well as increase a woman’s chance of acquiring and passing on sexually transmitted infections.
VivaGel BV is a water-based gel for topical treatment and rapid relief of BV. It is based on Starpharma’s SPL7013 astodrimer sodium, a dendrimer that blocks certain bacteria involved in BV and also has potent antiviral activity against certain viruses (HIV, HSV, HPV, Zika). Already approved in Europe for use against BV, VivaGel BV has now been developed for use against rBV, for which there are currently no clinically approved products.
“Antibiotic resistance is a major issue globally, and VivaGel BV offers an alternative to conventional antibiotic therapies for BV,” said Starpharma CEO Dr Jackie Fairley. “We know that patients and clinicians are very attracted to the non-antibiotic nature of the product, its novel mechanism of action on biofilm and the fact that it is not absorbed into the bloodstream, contributing to its excellent safety and tolerability profiles.”
The two double-blind, randomised, placebo-controlled trials, conducted in the US and Europe, were identical in design and enrolled 1223 women who had a history of rBV. Trial participants used either VivaGel BV or placebo gel on alternate days for 16 weeks. The primary endpoint of both studies was BV recurrence at or by Week 16 as diagnosed by clinical findings.
In the US trial, the rate of BV recurrence at or by Week 16 in the VivaGel BV group was 44.2%, as compared to 54.3% in the placebo group. In the European trial, the rate of BV recurrence in the VivaGel BV group was just 15.7% versus 22.6% for the placebo. The decrease in recurrence in the placebo group can be attributed to the fact that vaginally delivered placebos can have an effect on BV, compared to no intervention at all.
VivaGel BV also resulted in sustained benefits beyond cessation of treatment. Reduced recurrence of BV by the primary and secondary efficacy endpoints (including discharge, odour and clinical findings) were observed not only during the 16-week treatment period, but were also sustained during the 12-week follow-up period off-treatment.
“We are delighted to report these successful phase 3 trial results, in which VivaGel BV has demonstrated compelling efficacy in all six primary and secondary efficacy measures,” said Dr Fairley. “Our NDA [new drug application] for VivaGel BV for both treatment and rBV is well advanced, and we’ll be using these data to complete the clinical package for submission to the FDA and other regulatory authorities.”
The NDA will be submitted to the FDA as soon as practicable, with the initial sections of the rolling submission due for lodgement shortly. The data from these trials will also be submitted to other regulatory authorities, including in Europe, to expand the indications for VivaGel BV to include rBV.
Starpharma (ASX:SPL) shares closed yesterday 9.21% higher at $0.83.
Original Article: VivaGel BV trials declared a successNEXT ARTICLE
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